Inquiry™ IBI-87007Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05414734309912), received between Apr 10, 2020 and Apr 10, 2020 — classified as 1 injury.

The most frequently reported specific device problem is “Difficult to Remove” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryApr 10, 2020Difficult to Remove; Difficult to Remove

  DURING AN ATRIAL FIBRILLATION ABLATION PROCEDURE, WHEN MAPPING WAS PERFORMED IN THE LEFT ATRIUM, IT WAS FOUND THROUGH FLUOROSCOPY THAT THE PART BELOW THE LOOP OF THE CATHETER WAS KINKED. THE CATHETER WAS ATTEMPTED TO BE WITHDRAWN INTO THE SHEATH WITHOUT THE STRAIGHTENER, BUT WAS NOT SUCCESSFUL. THE KINK WAS ATTEMPTED TO BE STRAIGHTENED WITH A SNARE, BUT THE CATHETER STILL COULD NOT BE WITHDRAWN INTO THE SHEATH. THE ISSUE WAS RESOLVED AFTER THE CATHETER WAS STRAIGHTENED, ROTATED AND MANIPULATED INSIDE OF THE PATIENT. THE CATHETER WAS THEN WITHDRAWN INTO THE SHEATH AND REMOVED FROM THE PATIENT. UPON INSPECTION THE CATHETER WAS FOUND TO BE KINKED BUT NO OTHER DAMAGE WAS NOTED. THE PROCEDURE WAS COMPLETED BY USING ANOTHER CATHETER AND THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9947756 ↗